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Trial Outcomes & Findings for A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin (NCT NCT03019549)

NCT ID: NCT03019549

Last Updated: 2019-11-01

Results Overview

Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

42 participants

Primary outcome timeframe

1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose

Results posted on

2019-11-01

Participant Flow

11 participants completed Period 1 but did not enter Period 2 because they did not meet the genotype criteria.

Participant milestones

Participant milestones
Measure
Overall Study
All participants received: Period 1, Day 1: single, PO dose 20 mg rosuvastatin with a seven day wash-out. Period 2: Day 1-7 single, PO dose 50 mg lanabecestat (LY3314814) with a single 20 mg rosuvastatin dose coadminstered on Day 8
Period 1
STARTED
42
Period 1
Received 1 Dose of Study Drug
42
Period 1
COMPLETED
42
Period 1
NOT COMPLETED
0
Washout
STARTED
42
Washout
COMPLETED
31
Washout
NOT COMPLETED
11
Period 2
STARTED
31
Period 2
Received at Least 1 Dose of Study Drug
29
Period 2
COMPLETED
26
Period 2
NOT COMPLETED
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Overall Study
All participants received: Period 1, Day 1: single, PO dose 20 mg rosuvastatin with a seven day wash-out. Period 2: Day 1-7 single, PO dose 50 mg lanabecestat (LY3314814) with a single 20 mg rosuvastatin dose coadminstered on Day 8
Washout
DId not meet genotype criteria
11
Period 2
Adverse Event
2
Period 2
Physician Decision
2
Period 2
Withdrawal by Subject
1

Baseline Characteristics

A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Study
n=42 Participants
All participants who received at least 1 dose of study drug.
Age, Continuous
45.2 years
STANDARD_DEVIATION 13.1 • n=93 Participants
Sex: Female, Male
Female
20 Participants
n=93 Participants
Sex: Female, Male
Male
22 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants
n=93 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
Race (NIH/OMB)
White
42 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
42 Participants
n=93 Participants
Genotype rsl045642 (ABCB1)
Genotype A/A
10 Participants
n=93 Participants
Genotype rsl045642 (ABCB1)
Genotype A/G
15 Participants
n=93 Participants
Genotype rsl045642 (ABCB1)
Genotype G/G
6 Participants
n=93 Participants
Genotype rsl045642 (ABCB1)
Not performed
11 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose

Population: All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.

Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin

Outcome measures

Outcome measures
Measure
Rosuvastatin
n=31 Participants
20 mg rosuvastatin administered PO
Rosuvastatin + Lanabecestat (LY3314814)
n=26 Participants
20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination.
Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin
80 hours times nanogram per milliliter
Geometric Coefficient of Variation 47
78 hours times nanogram per milliliter
Geometric Coefficient of Variation 56

SECONDARY outcome

Timeframe: Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose

Population: All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.

Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)

Outcome measures

Outcome measures
Measure
Rosuvastatin
n=26 Participants
20 mg rosuvastatin administered PO
Rosuvastatin + Lanabecestat (LY3314814)
n=26 Participants
20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination.
Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)
3650 hours times nanograms per milliliter
Geometric Coefficient of Variation 25
3790 hours times nanograms per milliliter
Geometric Coefficient of Variation 21

SECONDARY outcome

Timeframe: .Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose

Population: All participants who received at least 1 dose of study drug and had evaluable PK data. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat

Outcome measures

Outcome measures
Measure
Rosuvastatin
n=26 Participants
20 mg rosuvastatin administered PO
Rosuvastatin + Lanabecestat (LY3314814)
n=26 Participants
20 mg rosuvastatin and 50 mg lanabescestat (LY3314814) administered in combination.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat
369 nanograms per milliliter
Geometric Coefficient of Variation 27
399 nanograms per milliliter
Geometric Coefficient of Variation 20

Adverse Events

20 mg Rosuvastatin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

50 mg Lanabecestat (LY3314814)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Lanabecestat (LY3314814) + 20 mg Rosuvastatin

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
20 mg Rosuvastatin
n=42 participants at risk
Period 1: rosuvastatin: 20 mg PO on Day 1
50 mg Lanabecestat (LY3314814)
n=29 participants at risk
Period 2: Day 1-7,50 mg lanabecestat (LY3314814) PO once daily (QD)
Lanabecestat (LY3314814) + 20 mg Rosuvastatin
n=26 participants at risk
Period 2: Lanabecestat (LY3314814) 50 mg PO Days 1-12 with a single dose of 20 mg rosuvastatin PO on Day 8
Injury, poisoning and procedural complications
Surgical skin tear
0.00%
0/42 • Up to 5 months
All participants who received at least 1 dose of study drug.
6.9%
2/29 • Number of events 2 • Up to 5 months
All participants who received at least 1 dose of study drug.
0.00%
0/26 • Up to 5 months
All participants who received at least 1 dose of study drug.
Nervous system disorders
Dizziness postural
0.00%
0/42 • Up to 5 months
All participants who received at least 1 dose of study drug.
0.00%
0/29 • Up to 5 months
All participants who received at least 1 dose of study drug.
11.5%
3/26 • Number of events 3 • Up to 5 months
All participants who received at least 1 dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Compnay

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60